Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication (ANSWER)
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Purpose
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
The expected benefits will be a result of the reduction of the percentage of ventricular pacing.
It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.
The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)
| Condition | Intervention | Phase |
|---|---|---|
|
Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients. |
Device: Symphony DR 2550 and REPLY DR cardiac pacemakers |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication |
- The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Evolution of paroxysmal AV blocks [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 640 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
AAIsafeR /SafeR Patient randomized with the SafeR switched ON
|
Device: Symphony DR 2550 and REPLY DR cardiac pacemakers
AAISafeR/SafeR ON
|
|
Experimental: 2
DDD(R) mode. Patients randomized with the SafeR mode switched OFF
|
Device: Symphony DR 2550 and REPLY DR cardiac pacemakers
DDD(R) (SafeR OFF)
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines.
- Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block.
- Patient implanted with a bipolar right atrial lead and a right ventricular lead
- Patient has signed a consent form after having received the appropriate information
Exclusion Criteria:
- Patient with permanent AF
- Patient suffering from sustained ventricular arrhythmias
- Patient with congenital complete heart block
- Patient with vasovagal syncope, carotid sinus syndrome
- Patient with AV node ablation
- Patient having suffered from a myocardial infarction within the last month
- Patient suffering from severe aortic stenosis
- Patient suffering from unstable angina pectoris
- Patient is not able to understand the study objectives and protocol or refuses to co-operate
- Patient is not available for scheduled follow-up
- Patient has a life expectancy less than one year
- Patient is included into another clinical study
- Patient is minor, this is < 18 years
- Patient is a pregnant woman
- Any patient with a contra-indication for the device labeling
Contacts and Locations| United States, Massachusetts | |
| 736 Cambridge Street | |
| Brighton, Massachusetts, United States, MA 02135 | |
| France | |
| CHU - Hopital Sud | |
| Amiens, France, 80054 | |
| Centre hospitalier de Béthune | |
| Béthune, France, 62408 | |
| CHU - Hopital Michallon | |
| Grenoble, France, 38043 | |
| CHP Beauregard | |
| Marseille, France, 13012 | |
| CHU A de Villeneuve | |
| Montpellier, France, 34295 | |
| Clinique Bizet | |
| Paris cedex 16, France, 75116 | |
| CHU Hopital C. Nicolle | |
| Rouen, France, 76035 | |
| CCN | |
| Saint Denis, France, 93207 | |
| CHU - Hopital Nord | |
| Saint Etienne, France, 42055 | |
| CHU Hautepierre | |
| Strasbourg, France, 67098 | |
| Clinique Pasteur | |
| Toulouse, France, 31076 | |
| CHU Hopital Trousseau | |
| Tours, France, 37044 | |
| CHU de Nancy | |
| Vandoeuvre les Nancy, France, 54511 | |
| Germany | |
| Charite Virchow | |
| Berlin, Germany | |
| Bernau hospital | |
| Bernau, Germany | |
| Braunschweig hospital | |
| Braunschweig, Germany, 38100 | |
| Elisabeth KH Essen | |
| Essen, Germany, D-45138 | |
| Leipzig Uni | |
| Leipzig, Germany, 04103 | |
| Lübeck Uni | |
| Lübeck, Germany, D-23538 | |
| Lüdenscheid hospital | |
| Lüdenscheid, Germany, 58515 | |
| Mainz Uni | |
| Mainz, Germany, 55101 | |
| München Innenstadt | |
| München, Germany, 80336 | |
| Remscheid hospital | |
| Remscheid, Germany, 42859 | |
| Ulm Uni | |
| Ulm, Germany, 89081 | |
| Italy | |
| Clinica Villa Pini d'Abruzzo | |
| Chieti, Italy, 66100 | |
| Osp Civile di Montebelluna | |
| Conegliano, Italy, 31015 | |
| Ospedale Umberto I | |
| Mestre, Italy, 30173 | |
| Presidio Ospedaliero di Mirano | |
| Mirano, Italy, 30035 | |
| Azienda Ospedaliera S. Maria | |
| Terni, Italy, 05100 | |
| Spain | |
| Complejo Hospitalario Arquitecto Marcide | |
| Ferrol, Spain, 15405 | |
| Hospital Universitario de Madrid | |
| Madrid, Spain, 28041 | |
| Hospital Montecelo | |
| Mourente, Spain, 36071 | |
| Povisa | |
| Salamanca, Spain | |
| Hospital Clinico universitario de Santiago | |
| Santiago de Compostela, Spain, 15706 | |
| Complejo Hospitalario Xeral-Cies | |
| Vigo, Spain, 3204 | |
| United Kingdom | |
| William Harvey Hospital | |
| Ashford, United Kingdom, Kent TN24 OLZ | |
| Principal Investigator: | Stockburger Martin, MD | Head of Pacemaker/Defibrillator/CRT department |
More Information
No publications provided
| Responsible Party: | Sorin Group |
| ClinicalTrials.gov Identifier: | NCT00562107 History of Changes |
| Other Study ID Numbers: | ANSWER - IBSY02, IBSY02 |
| Study First Received: | November 20, 2007 |
| Last Updated: | September 7, 2012 |
| Health Authority: | France: Institutional Ethical Committee France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Ethics Committee Italy: Ethics Committee |
Keywords provided by Sorin Group:
|
Minimized ventricular pacing, clinical outcome, SafeR, AAIsafeR, dual chamber pacemaker therapy, % of ventricular pacing, hospitalizations, symptomatic AF |
ClinicalTrials.gov processed this record on May 19, 2013